Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus - Full Text View

Purpose

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

Condition	Intervention	Phase
Type-2-diabetes Mellitus New Onset	Drug: Placebo of DLBS3233 Drug: DLBS3233 Other: Lifestyle modification	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:

Reduction of A1c level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reduction of A1c level from baseline to Week 12 of treatment

Secondary Outcome Measures:

Reduction of venous FPG [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment
Reduction of venous 2h-PG [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment
Response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of subjects with FPG < 110 mg/dL and/or reduction of at least 10% in FPG level from baseline to Week 12 of treatment
Change in fasting insulin level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in fasting insulin level from baseline to Week 12 of treatment
Change in HOMA-IR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in HOMA-IR from baseline to Week 12 of treatment
Change in HOMA-B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in HOMA-B from baseline to Week 12 of treatment
Change in adiponectin level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in adiponectin level from baseline to Week 12 of treatment
Change in lipid profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment
Change in body weight [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
Change in body weight from baseline to Week 6 and Week 12 of treatment
Vital signs [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]
Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12
Liver function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12
Renal function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Renal function (serum creatinine level) will be evaluated at baseline and Week 12
Electrocardiography (ECG) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
ECG will be evaluated at baseline and Week 12
Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Adverse events as well as number of subjects experienced the events will be observed and evaluated throughout study period (12 weeks) and until all adverse events have been recovered or stabilized

Estimated Enrollment:	104
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Treatment I (control) Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification	Drug: Placebo of DLBS3233 Placebo of DLBS3233 once daily for 12 weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
Experimental: Treatment II 100 mg DLBS3233 once daily for 12 weeks + lifestyle modification	Drug: DLBS3233 100 mg DLBS3233 once daily for 12 weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Detailed Description:

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy.

Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects with age of 18-60 years
BMI ≥ 18.5 kg/m2
Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%)
FPG ≤ 183 mg/dL
Hemoglobin level of ≥ 10.0 g/dL
Serum ALT ≤ 2.5 times upper limit of normal
Serum creatinine < 1.5 times upper limit of normal

Exclusion Criteria:

Female of childbearing potential
Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
History of renal and/or liver disease
History of or the presence of any clinical evidence of malignancies
Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
Current treatment with systemic corticosteroids or herbal (alternative) medicines
Participation in any other intervention trial within 30 days prior to Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645332

Contacts

Contact: R. Djokomoeljanto, Prof,Dr,dr,SpPD,KEMD,FINASIM

+62811 299711

Locations

Indonesia
Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital	Recruiting
Semarang, Jawa Tengah, Indonesia, 50231
Contact: R. Djokomoeljanto, Prof,Dr,dr,SpPD,KEMD,FINASIM +6224 8454873, 8446757 endokrin_smg@yahoo.com
Sub-Investigator: Darmono, Prof,Dr,dr,SpPD,KEMD,FINASIM
Sub-Investigator: Tony Suhartono, dr,SpPD,KEMD,FINASIM
Sub-Investigator: K. Heri Nugroho HS, dr,SpPD,KEMD,FINASIM

Sponsors and Collaborators

Dexa Medica Group

Investigators

Principal Investigator:

R. Djokomoeljanto, Prof,DR,dr,SpPD,KEMD,FINASIM

Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia

More Information

No publications provided

Responsible Party:	Dexa Medica Group
ClinicalTrials.gov Identifier:	NCT01645332 History of Changes
Other Study ID Numbers:	DLBS3233-0912
Study First Received:	July 18, 2012
Last Updated:	February 12, 2013
Health Authority:	Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:

DLBS3233
new onset
type-2-diabetes mellitus
oral anti-hyperglycemic agent

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013